A Bundled Intervention

NCT06593093 | Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: IRB-300013272R61DA062351
• Study Type: interventional
• Target: 190
• Locations: 1 country
• Sites: 1

Brief Summary

Opioid overdose deaths have reached historically high records in the United States and are particularly concentrated among patients after emergency department (ED) discharge. Evidence-based treatment modules to reduce repeat opioid overdose and mortality are lacking in this patient population. A bundled intervention is proposed, including telehealth, peer support specialist, buprenorphine, and linkage for definitive care, that is designed to increase treatment uptake in this patient population post-ED discharge, reduce repeat opioid overdoses, and end overdose deaths.

Conditions

Opioid Use Disorder; Opioid Overdose

Keywords

Emergency department; post discharge; buprenorphine

Outcome Measures

Primary Outcomes (3)

• participant retention rate

  measure the total number of participants who complete 1- month and 3-month treatment in the study

  1 month and 3 months post ED discharge

• buprenorphine adherent rate

  checking prescription rate and patients' report of their taking medication rate

  1 month and 3 months post ED discharge

• linkage rate to addiction treatment programs

  patients' self report and reports from addiction treatment programs

  1 month and 3 months post ED discharge

Study Arms (3)

phase 1

EXPERIMENTAL

After completing screening questions and obtaining consent, eligible participants will complete their baseline procedures and measures. All participants will then start the experimental, i.e., bundled intervention, the first week after their ED discharge, including peer support service and buprenorphine treatment with addiction physicians using telehealth. Each participant will be in the study for 3 months. During the study period, participants will be sent survey links to their cell phones and/or emails to complete self-report questionnaires via the Research Electronic Data Capture (REDCap) at 1-month and 3-month for follow-up assessments. Peers will remind the participants to complete the survey.

Other: a bundled intervention

phase 2- experimental

EXPERIMENTAL

Participants will be enrolled the same way as in phase 1. After their enrollment, participants will be randomized to either the experimental (bundled intervention) group or the control (usual care group). Bundled intervention will have the same components as in the phase 1, including peer support, buprenorphine treatment, and telehealth up to 3 months after ED/hospital discharge, and linkage to definitive addiction treatment programs. Participants will be sent survey links to their cell phones and emails to complete self-report questionnaires via REDCap at 1- and 3-month for follow-up assessments. Participants will be reminded via text messages and/or emails to complete the survey twice per day 5 days prior to their follow-up assessments.

Other: a bundled intervention

phase 2- control

PLACEBO COMPARATOR

Participants who are randomized to the control group will receive the usual care that has been established in the ED at UAB hospital. The current usual care at the UAB ED includes a thorough assessment, buprenorphine initiation as appropriate, peer referral, and a written list of buprenorphine clinics. Participants will also receive information about community-based substance use treatment programs. However, these services are at the participant's own discretion to navigate and attend after ED discharge. Participants will be sent survey links to their cell phones and emails to complete self-report questionnaires via REDCap at 1- and 3-month for follow-up assessments. Participants will be reminded via text messages and/or emails to complete the survey twice per day 5 days prior to their follow-up assessments.

Other: control group

Interventions

a bundled intervention OTHER

a bundled intervention, including peer support, buprenorphine (ranging from 4mg-24mg, oral, daily), telehealth, and community-based addiction programs.

phase 1; phase 2- experimental

control group OTHER

participants will not be intervened with this bundled treatment, but continue the usual care that has been established at UAB ED.

phase 2- control

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• discharged from the ED and inpatient settings at the UAB hospital
• years or older (the age of majority in Alabama);
• diagnosis of OUD and experiencing opioid overdose in the last 12 months;
• prescribed buprenorphine in the ED and willing to continue buprenorphine post-ED discharge;
• English speaking;
• not actively psychotic and suicidal, or cognitively impaired.
• Patients who are admitted to the hospital from the ED will be eligible for enrollment.

You may not qualify if:

• living in a restricted environment (e.g., prison or jail facility, etc.);
• currently enrolled in other clinical studies;
• anticipated to take other prescribed opioids except buprenorphine for a medical condition longer than three months;
• known allergic reaction to buprenorphine;
• critically ill or injured;
• females with pregnancy (they are anticipated to request a higher level of care).
• living outside of Alabama

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

UAB

Birmingham, Alabama, 35294, United States

RECRUITING

MeSH Terms

Conditions

Opioid-Related Disorders; Opiate Overdose; Emergencies

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Drug Overdose; Prescription Drug Misuse; Drug Misuse; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Li Li, MD;PhD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Li Li, MD;PhD

CONTACT

2059346269; liyli@uabmc.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Study Record Dates

• First Submitted: September 9, 2024
• First Posted: September 19, 2024
• Study Start: February 13, 2025
• Primary Completion (Estimated): November 30, 2030
• Study Completion (Estimated): November 30, 2030
• Last Updated: February 23, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

US (1)